Post

Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information

This guidance outlines procedures for submitting, reviewing, and responding to requests for information regarding device classification and applicable requirements under section 513(g) of the FD&C Act. It helps manufacturers understand how to obtain FDA's views about the classification of their device and associated regulatory requirements.

Posted
By ReguVirta
3 min read

What You Need to Know? 👇

What is a Section 513(g) Request for Information and when should I use it?

A Section 513(g) request is a formal mechanism to obtain FDA’s views about device classification and regulatory requirements. Use it when you need clarification on which class your device falls into or what regulatory requirements apply to your specific device.

How long does FDA take to respond to a 513(g) request?

FDA intends to issue a response within 60 days of receipt of your complete 513(g) Request for Information and payment of the required user fee. The review begins once both the submission and fees are received.

What are the user fees for submitting a 513(g) request?

Section 738(a)(2)(A)(ix) of the FD&C Act requires FDA to collect user fees for 513(g) requests. FDA cannot accept your request for review until all fees are paid, including establishment registration fees. Check the current fee schedule on FDA’s website.

Can I modify my 513(g) request after submission?

No, once FDA receives your 513(g) request and user fee, you cannot modify it by adding new questions, uses, or technologies. Any additions would be considered a new request requiring a separate user fee and response.

What information must be included in a 513(g) request submission?

Your submission must include a signed cover letter identifying it as a “513(g) Request,” device description with materials and components, intended uses, proposed labeling or promotional materials, and specific questions about classification or regulatory requirements.

Does a 513(g) response constitute FDA clearance or approval for marketing?

No, FDA’s response to a 513(g) request is not a device classification decision and does not constitute clearance or approval for marketing. It provides information based solely on what you submitted and requires separate submissions for actual marketing authorization.

What You Need to Do 👇

  1. Review existing classification resources and databases before submitting a 513(g) request
  2. Prepare a complete submission package including:
    • Signed cover letter with required information
    • Comprehensive device description
    • Detailed intended use information
    • Available labeling/promotional materials
  3. Submit electronically via CDRH Portal (preferred) or other accepted methods
  4. Pay required user fees before submission
  5. Ensure submission addresses only one product
  6. Be prepared to respond to FDA requests for additional information within 30 days
  7. Consider contacting Office of Combination Products first if unclear about product jurisdiction
  8. For specific testing recommendations, consider submitting a Q-submission instead of or after 513(g)

Key Considerations

Software

  • Description of operational principles if device contains software/firmware should be included in the submission

Labelling

  • Proposed labeling or promotional material must be included in the submission
  • If available, include labeling/promotional material of similar legally marketed devices
  • Prescription vs OTC use status should be specified

Other considerations

  • Submission must include a signed cover letter identifying it as a “513(g) Request for Information”
  • Complete device description including materials, components, photographs/drawings
  • Description of device uses, including disease/condition, patient population, environment of use
  • User fees must be paid before FDA will review the submission
  • One submission should only seek information for a single product
  • FDA will respond within 60 days of receipt
  • Submissions can be made electronically via eCopy or eSTAR (preferred methods)

Relevant Guidances 🔗

Related references and norms 📂

  • 21 CFR 860.3(i): Definition of “generic type of device”
  • 21 CFR parts 862-892: Device classification regulations
  • 21 CFR part 807, subpart E: Premarket Notification Procedures

Original guidance

  • Device Classification and Regulatory Requirements: Procedures for 513(g) Requests for Information
  • HTML / PDF
  • Issue date: 2024-08-23
  • Last changed date: 2024-08-22
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Labeling, Biologics, Administrative / Procedural
  • ReguVirta ID: c24a25e3c573df7b9b6d343203399e29
FDA guidance, Final
Medical Devices Premarket Labeling Biologics Administrative / Procedural
This post is licensed under CC BY 4.0 by the author.